Hysterectomy Leiomyosarcoma Lawsuits Filed Over Use of Ethicon Morcellators

Over the first week of this month, at least two new wrongful death lawsuits have been filed against Johnson & Johnson’s Ethicon subsidiary, alleging that two women died from the spread of leiomyosarcoma following a laparoscopic hysterectomy where the company’s power morcellators were used.

The cases join a growing number of similar leimyosarcoma lawsuits filed against Ethicon and other manufacturers of morcelltors, which have been used in recent years to allow doctors to perform a hysterectomy or uterine fibroid removal through a minimally invasive, laparoscopic procedure.

The devices are used to cut up and remove tissue through a small incision in the abdomen. However, over the past year concerns have emerged about the safety of the devices, since some women may have unsuspected cancer hidden within their uterus, which doctors are unable to detect before the procedure.

For these women, the hyesterectomy morcellation may cause the dissemination of leiomyosarcoma or other aggressive uterine cancers, greatly reducing the changes for long-term survival and their overall quality of life.

Power Morcellator Wrongful Death Lawsuits

One complaint (PDF) filed last week was brought by the widower of Cynthia Ostrander, a South Carolina woman who died in September 2014, less than two years after undergoing a total laparoscopic robotic hysterectomy and cystocopy for uterine fibroids, where an Ethicon Gynecare Morcellex was used.

According to allegations raised in the wrongful death lawsuit filed by her husband, John, Ostrander underwent all reasonable and standard procedures to diagnose cancer before surgery, but none was detected.

“The leiomyosarcoma cancer tissue in Ms. Ostrander would have remained encapsulated but for the tissue shredding and tissue dissemination of the GYNECARE MORCELLEX,” the lawsuit states. “The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Ms. Ostrander’s abdominal cavity. That action changed the course and prognosis of the leiomyosarcoma cancer which had been encapsulated; upstaging it and profoundly injuring the patient, leading to her death.”

Ostrander died of leiomyosarcoma cancer only two months after Johnson & Johnson announced an Ethicon power morcellator recall, indicating that it would no longer manufacturer the devices since there was not way to make them safe and reduce the risk of spreading undiagnosed cancer.

On February 5, a similar lawsuit was filed by Arthur Johnson on behalf of himself and his late wife, Jonel Rollins-Davis-Johnson. According to the complaint (PDF) filed in the U.S. District Court for the Eastern District of Pennsylvania, Davis-Johnson underwent robotic total laparoscopic hysterectomy in June 2012, involving an Ethicon Morcellex Sigma Tissue Morcellator.

Davis-Johnson’s surgery even involved the use of an endoscopic bag, which some defenders of power morcellators have indicated will catch tissue debris and prevent the spread of cancer cells. However, the surgical bag appears to have failed to prevent Davis-Johnson’s leiomyosarcoma cancer from spreading following the surgery.

The lawsuit indicates that Davis-Johnson also underwent testing and evaluation prior to the procedure, and there was no evidence of cancer. Her husband also indicates that she was not warned of the high-risk that use of a laparoscopic morcellator could disseminate and upstage hidden cancer.

“Long before [Davis-Johnson] underwent surgery in 2012, Defendants knew or should have known that their Laparoscopic Power Morcellators could cause occult malignant tissue fragments to be disseminated and implanted in teh body, which, in turn, upstages any cancer present and significantly worsens a woman’s chance of survival,” according to the wrongful death lawsuit.

After the tissue removed during Davis-Johnson’s hysterectomy was diagnosed as containing leiomyosarcoma cancer cells, she underwent another operation in August 2012, which found that the cancer had already spread to her right fallopian tube. She died on February 6, 2013.

Power Morcellator Cancer Concerns

Amid aggressive marketing by Ethicon and other manufacturers, morcellators were rapidly adopted throughout the medical community over the past decade, providing a less invasive procedure that results in reduced recovery times, less scaring and less change of infections or other complications. However, most doctors remained unaware that some women may face a risk of having undiagnosed cancer spread by the devices.

Estimates now suggest that about one out of every 350 women undergoing a laparoscopic supracervical hysterectomy with morcellation may have unsuspected sarcoma, which doctors are unable to detect before the surgery.

Over the summer, an FDA advisory panel was convened to evaluate the available data on the controversial devices, and determined that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.

In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.

The two latest complaints join about a dozen other hysterectomy leiomyosarcoma lawsuits filed by women and families throughout the U.S., raising nearly identical allegations that the manufacturers sold unreasonably dangerous devices without providing adequate warnings.

Plaintiffs maintain that the spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.